BronchiectasisPhase 2NCT04396366
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis
A Phase 2 study testing QBW251 in people with Bronchiectasis, run by Novartis Pharmaceuticals at 14 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in patients with bronchiectasis will demonstrate clinical safety and efficacy related to improved mucociliary clearance with reduced bacterial colonization as potential drivers of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- QBW251
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 2 Feb 2021to 21 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years at screening.
- Proven diagnosis of bronchiectasis by chest CT at screening as determined by investigator.
- Evidence of sputum bacterial load of ≥106 CFU/mL with at least one potentially pathogenic microorganism (H. Influenzae, M catarrhalis, S aureus, S pneumoniae, Enterobacteriaceae, P aeruginosa, Stenotrophomonous maltophilia, or any potential pathogenic non-fermenting Gram-negative bacteria measured by dilution/outgrowth).
- Documented history of at least one bronchiectasis exacerbation between January 2019 and study screening.
- Patients with bronchial hypersecretion, defined as productive cough that occurred on most days (defined as >50% days) for at least three consecutive months within 12 months prior to screening, as assessed by documentation of patient recollection (anamnesis) or documented in patients' record.
- Patients were allowed to stay on fixed or free combinations of LABA/LAMA or LABA/ICS or LABA/LAMA/ICS as maintenance therapy if they were treated with them at a stable dose for the last 3 months prior to screening. Patients were also allowed to stay on macrolides as maintenance therapy if they were treated with them at a stable dose, 3 months before screening. Patients were allowed to use mucolytics or hyperosmolar agents if they were treated with them before study start.
- If prescribed, patients were included in the study with unchanged chest physiotherapy for at least 4 weeks prior to screening.
- Clinically stable pulmonary status in the opinion of the investigator and unlikely to require any change in the standard regimen of care during the course of the study.
Who cannot join
- Patients with a history of long-QT syndrome or the QTcF interval at screening and baseline was prolonged (QTcF > 450 ms in males, > 460 ms in females).
- Patients with a history or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure. A history of resolved Hepatitis A was not exclusionary. Patients with a prothrombin time international normalized ratio (PT/INR) of more than 1.5 × ULN at screening. Patients excluded for the PT/INR of more than 1.5 x ULN could be re-screened when the values returned to normal.
- History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there was evidence of local recurrence or metastases. Patients with segmentectomy for other reasons than cancer were allowed to be included in the study. Patients with a history of cancer and 5 years or more disease free survival time might be included in the study by agreement with Novartis Medical Monitor on a case-by-case basis.
- Patients requiring long-term oxygen therapy for chronic hypoxemia. This was typically patients requiring oxygen therapy >12 h per day delivered by home oxygen cylinder or concentrator. Note: Nocturnal oxygen therapy for transient oxygen desaturations during sleep was allowed.
- Patients with bronchiectasis who had a pulmonary exacerbation with a deterioration in three or more of the following key symptoms for at least 48 h:
- cough;
Show all 21Show fewer
- sputum volume and/or consistency;
- sputum purulence;
- breathlessness and/or exercise tolerance;
- fatigue and/or malaise;
- hemoptysis And A clinician determined that a change in bronchiectasis treatment was required (e.g., requiring systemic glucocorticosteroid treatment and/or systemic or inhaled antibiotics) within 4 weeks prior to screening.
- In the event of an exacerbation occurring 4 weeks before screening, or between the screening and baseline (please see definition above), the participant was not to be enrolled. The participant might be rescreened once, 4 weeks after the resolution of exacerbation.
- Participants with bronchiectasis requiring therapy that might interfere with the assessment of QBW251 efficiency or who were unlikely to respond to QBW251 as follows:
- Participants with suspected active pulmonary tuberculosis or currently being treated for active pulmonary tuberculosis were not allowed. Note: Participants with a history of pulmonary tuberculosis could be enrolled if they met the following requirements: history of appropriate drug treatment followed by negative imaging results within 12 months prior to baseline visit suggesting low probability of recurrent active tuberculosis
- Patients with active allergic bronchopulmonary aspergillosis and asthma as primary diagnosis.
- Patients with cystic fibrosis
- Current or ex-smokers with severe emphysema.
- Participants with another concomitant pulmonary disease according to the definition of the International ERS/ATS guidelines, including but not limited to idiopathic pulmonary fibrosis (IPF), sarcoidosis or other granulomatous or infectious process. Concomitant COPD and asthma with characteristics of airway hyperresponsiveness as well as COPD-Asthma overlap syndrome were allowed as long as it was not the main, primary diagnosis in the opinion of the investigator. Primary ciliary dyskinesia (PCD) was allowed.
- Participants currently receiving treatment for nontuberculous mycobacterial (NTM) pulmonary disease. If performed, patients with one or more positive cultures in the last 12 months for M. avium complex, M. abscessus complex, M. kansasii, M. malmoense, M. xenopi, M. simiae or M. chelonae, unless all subsequent NTM cultures (at least two) were negative and in the opinion of the investigator the patient did not met ATS criteria for NTM-pulmonary disease.
- Patients receiving any medication that might influence the response to treatment within 4 weeks prior to screening including systemic or inhaled steroids (ICS alone), or other systemic immunomodulators, recombinant human DNAse, any systemic or inhaled antibiotics.
- Patients with a body mass index (BMI) of more than 40 kg/m^2
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United Kingdom7 sites
Novartis Investigative Site
Cambridge, CB2 0AY
Novartis Investigative Site
Edinburgh, EH10 5HF
Novartis Investigative Site
Leeds, West Yorkshire, LS9 7TF
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
Liverpool, L9 7AL
Novartis Investigative Site
London, SW3 6PH
Novartis Investigative Site
Manchester, M23 9LT
Germany3 sites
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Mainz, 55128
China2 sites
Novartis Investigative Site
Guangzhou, Guangdong, 510120
Novartis Investigative Site
Shanghai, 200433
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Girona, Catalonia, 17007
About this study
Official title: A Randomized, Subject- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Patients With Bronchiectasis
The purpose of this study is to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in patients with bronchiectasis will demonstrate clinical safety and efficacy related to improved mucociliary clearance with reduced bacterial colonization as potential drivers of airway obstruction, reduced airway inflammation, exacerbations and mucus load, improved lung function, clinical symptoms and quality of life to support further development in bronchiectasis.
Read the detailed description
This was a randomized, participant- and investigator-blinded, placebo-controlled, parallel-group study investigating the preliminary efficacy and safety of QBW251 administered orally for 12 weeks in participants with bronchiectasis. Approximately 72 subjects were planned to be randomized in a 1:1 ratio to receive either QBW251 or placebo in order to achieve 60 subjects to complete the treatment period based on the assumption of a 16% drop-out rate. However, the study was prematurely terminated due to a Novartis strategic decision. As a result, only 42 participants were randomized to either the QBW251 300 mg b.i.d group or the placebo group.
The study consisted of the screening, baseline/Day 1, treatment period, and end of study assessments (EOS) visit followed by an additional post-treatment safety follow up via phone call. The total duration for each patient in the study was up to approximately 19 weeks.
- Conditions
- Bronchiectasis
- Being tested
- QBW251, Placebo
- Keywords
- Bronchiectasis, QBW251, colony forming units
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBW251Drug
QBW251, 300 mg, oral use, one capsule, twice daily.
PlaceboDrug
Also called Comparator
Matching placebo, 300 mg, oral use, one capsule, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| QBW251 300 mg b.i.d | Experimental | Participants received QBW251 300 mg orally, twice daily (b.i.d.), for 12 weeks. Receives: Drug: QBW251 |
| Placebo | Placebo comparator | Participants received matching placebo, b.i.d., for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline In Bacterial Load Colony-forming Units of Potentially Pathogenic Microorganisms in Sputum at Week 12
This measure reflects the amount of bacteria present in a patient's lungs.
Measured: Baseline, 12 weeks
Secondary outcomes (25)
Number of Participants With Absence of Any Colony-forming Units of Potentially Pathogenic Bacteria Sputum
Measured: Baseline, 12 weeks
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain)
The Quality of Life Questionnaire for Bronchiectasis (QOL-B) is a disease-specific questionnaire developed for non-cystic fibrosis bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension is scored separately on a scale of 0 to 100, and higher scores represent better outcomes. Only the respiratory symptoms domain score is reported for this outcome measure.
Measured: Baseline, Days 28, 56, 84
Change From Baseline in Fibrinogen Plasma Concentration
Measured: Baseline, 12 weeks
Change From Baseline in Daily Rescue Medication Use (Salbutamol/Albuterol)
The total number of puffs of rescue medication was divided by the total number of (full or half) days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient for the given visit interval.
Measured: Baseline, 12 weeks
Change From Baseline in Pre-bronchodilator Forced Exploratory Volume in the First Second (FEV1)
FEV1 is the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Baseline, Days 28, 56, 84
Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline, Days 28, 56, 84
Change From Baseline in Bronchus Region Pi10
Pi10 is the square root of the wall area for an idealized airway with a luminal perimeter of 10 mm. Pi10 is the most commonly used measure of wall thickening and represents a regional estimate of the small airways across the whole lung or a particular lobe. Measured by high resolution computed tomography (HRCT).
Measured: Baseline, 12 weeks
Change From Baseline in Region Percent Below or Equal to -856 Hounsfield Units (HU)
The region percent below or equal to -856 HU represents air trapping, which was evaluated by HRCT in the whole lung and in the regions (thirds, lobes).
Measured: Baseline, 12 weeks
Change From Baseline in Region Air Volume
Measured by HRCT
Measured: Baseline, 12 weeks
Change From Baseline in Segment Average Inner Area
Measured by HRCT
Measured: Baseline, 12 weeks
Change From Baseline in Segment Average Major Inner Diameter
Measured by HRCT
Measured: Baseline, 12 weeks
Change From Baseline in Segment Average Minor Inner Diameter
Measured by HRCT
Measured: Baseline, 12 weeks
Change From Baseline in Segment Average Outer Area
Measured by HRCT
Measured: Baseline, 12 weeks
Change From Baseline in Segment Average Wall Area Fraction
Wall area fraction or ratio was calculated by dividing the wall area of the corresponding segment to the total airway area. Measured by HRCT.
Measured: Baseline, 12 weeks
Change From Baseline in Segment Average Wall Thickness
Measured by HRCT
Measured: Baseline, 12 weeks
Change From Baseline in Segment Wall Area Percent
Measured by HRCT
Measured: Baseline, 12 weeks
Change From Baseline in Segment Wall Area
Measured by HRCT
Measured: Baseline, 12 weeks
Cmax of QBW251
Maximum (peak) plasma concentration of QBW251
Measured: 1h, 2h, 3h, 4h, 6h and 8h post-dose on Days 1 and 28, and 3h post-dose on Day 56 and Day 84
Ctrough of QBW251
Trough (pre-dose) plasma concentration of QBW251
Measured: Pre-dose Day 1, Day 28, Day 56, Day 84
Cmax of QBW251 for a Serial PK Set
Measured: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Ctrough of QBW251 for a Serial PK Set
Measured: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
AUClast of QBW251 for a Serial PK Set
Area under the concentration-time curve up to the last measurable concentration of QBW251 (AUClast)
Measured: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Tmax of QBW251 for a Serial PK Set
Time to reach maximum (peak) plasma concentration after single-dose administration
Measured: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
AUC0-12h of QBW251 for a Serial PK Set
Twelve-hour AUC
Measured: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Tlast of QBW251 for a Serial PK Set
Tlast is the last measurable concentration sampling time.
Measured: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start2 Feb 2021
- Primary completion15 Jun 2023
- Study completion21 Jun 2023
Why it stopped: Strategic business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovative Medicines Initiative
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396366
- Sponsor's protocol ID
- CQBW251C12201
- Status last verified
- Sep 2025
- First submitted
- 18 May 2020
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT04396366
- Acronym / sponsor ID
- CQBW251C12201
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, QBW251, colony forming units
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic business decision
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Innovative Medicines Initiative
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in patients with bronchiectasis will demonstrate clinical safety and efficacy related to improved mucociliary clearance with reduced bacterial colonization as potential drivers of airway obstruction, reduced airway inflammation, exacerbations and mucus load, improved lung function, clinical symptoms and quality of life to support further development in bronchiectasis.
Detailed description
This was a randomized, participant- and investigator-blinded, placebo-controlled, parallel-group study investigating the preliminary efficacy and safety of QBW251 administered orally for 12 weeks in participants with bronchiectasis. Approximately 72 subjects were planned to be randomized in a 1:1 ratio to receive either QBW251 or placebo in order to achieve 60 subjects to complete the treatment period based on the assumption of a 16% drop-out rate. However, the study was prematurely terminated due to a Novartis strategic decision. As a result, only 42 participants were randomized to either the QBW251 300 mg b.i.d group or the placebo group.
The study consisted of the screening, baseline/Day 1, treatment period, and end of study assessments (EOS) visit followed by an additional post-treatment safety follow up via phone call. The total duration for each patient in the study was up to approximately 19 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QBW251 300 mg b.i.d | Experimental | Drug: QBW251Participants received QBW251 300 mg orally, twice daily (b.i.d.), for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo, b.i.d., for 12 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients aged ≥18 years at screening.
- Proven diagnosis of bronchiectasis by chest CT at screening as determined by investigator.
- Evidence of sputum bacterial load of ≥106 CFU/mL with at least one potentially pathogenic microorganism (H. Influenzae, M catarrhalis, S aureus, S pneumoniae, Enterobacteriaceae, P aeruginosa, Stenotrophomonous maltophilia, or any potential pathogenic non-fermenting Gram-negative bacteria measured by dilution/outgrowth).
- Documented history of at least one bronchiectasis exacerbation between January 2019 and study screening.
- Patients with bronchial hypersecretion, defined as productive cough that occurred on most days (defined as >50% days) for at least three consecutive months within 12 months prior to screening, as assessed by documentation of patient recollection (anamnesis) or documented in patients' record.
Key exclusion criteria (21 listed)
- Patients with a history of long-QT syndrome or the QTcF interval at screening and baseline was prolonged (QTcF > 450 ms in males, > 460 ms in females).
- Patients with a history or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure. A history of resolved Hepatitis A was not exclusionary. Patients with a prothrombin time international normalized ratio (PT/INR) of more than 1.5 × ULN at screening. Patients excluded for the PT/INR of more than 1.5 x ULN could be re-screened when the values returned to normal.
- History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there was evidence of local recurrence or metastases. Patients with segmentectomy for other reasons than cancer were allowed to be included in the study. Patients with a history of cancer and 5 years or more disease free survival time might be included in the study by agreement with Novartis Medical Monitor on a case-by-case basis.
- Patients requiring long-term oxygen therapy for chronic hypoxemia. This was typically patients requiring oxygen therapy >12 h per day delivered by home oxygen cylinder or concentrator. Note: Nocturnal oxygen therapy for transient oxygen desaturations during sleep was allowed.
- Patients with bronchiectasis who had a pulmonary exacerbation with a deterioration in three or more of the following key symptoms for at least 48 h:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QBW251QBW251, 300 mg, oral use, one capsule, twice daily. | Drug | QBW251 300 mg b.i.d |
| PlaceboAlso: ComparatorMatching placebo, 300 mg, oral use, one capsule, twice daily. | Drug | Placebo |
Primary outcome
Change From Baseline In Bacterial Load Colony-forming Units of Potentially Pathogenic Microorganisms in Sputum at Week 12
Time frame: Baseline, 12 weeks
This measure reflects the amount of bacteria present in a patient's lungs.
25 secondary outcomes
Number of Participants With Absence of Any Colony-forming Units of Potentially Pathogenic Bacteria Sputum
Time frame: Baseline, 12 weeks
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain)
Time frame: Baseline, Days 28, 56, 84
Change From Baseline in Fibrinogen Plasma Concentration
Time frame: Baseline, 12 weeks
Change From Baseline in Daily Rescue Medication Use (Salbutamol/Albuterol)
Time frame: Baseline, 12 weeks
Change From Baseline in Pre-bronchodilator Forced Exploratory Volume in the First Second (FEV1)
Time frame: Baseline, Days 28, 56, 84
Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)
Time frame: Baseline, Days 28, 56, 84
Change From Baseline in Bronchus Region Pi10
Time frame: Baseline, 12 weeks
Change From Baseline in Region Percent Below or Equal to -856 Hounsfield Units (HU)
Time frame: Baseline, 12 weeks
Change From Baseline in Region Air Volume
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Average Inner Area
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Average Major Inner Diameter
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Average Minor Inner Diameter
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Average Outer Area
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Average Wall Area Fraction
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Average Wall Thickness
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Wall Area Percent
Time frame: Baseline, 12 weeks
Change From Baseline in Segment Wall Area
Time frame: Baseline, 12 weeks
Cmax of QBW251
Time frame: 1h, 2h, 3h, 4h, 6h and 8h post-dose on Days 1 and 28, and 3h post-dose on Day 56 and Day 84
Ctrough of QBW251
Time frame: Pre-dose Day 1, Day 28, Day 56, Day 84
Cmax of QBW251 for a Serial PK Set
Time frame: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Ctrough of QBW251 for a Serial PK Set
Time frame: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
AUClast of QBW251 for a Serial PK Set
Time frame: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Tmax of QBW251 for a Serial PK Set
Time frame: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
AUC0-12h of QBW251 for a Serial PK Set
Time frame: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Tlast of QBW251 for a Serial PK Set
Time frame: Pre-dose, 1h, 2h, 3h, 4h, 6h and 8h post-dose on Day 1 and Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QBW251 in people with Bronchiectasis, run by Novartis Pharmaceuticals at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, Germany, China, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline In Bacterial Load Colony-forming Units of Potentially Pathogenic Microorganisms in Sputum at Week 12 (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.